Orange Book product · Brand (NDA)

ACUVAIL

KETOROLAC TROMETHAMINE

Brand (NDA)NDA 022427RX ABBVIE

Jul 22, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 22, 2009
17 yr 2 mo ago
Today
Patent 8512717 expires
Listed drug product patent expiration.
Mar 07, 2028
in 1 yr 9 mo
Patent 9192571 expires
Listed drug product patent expiration.
Mar 07, 2028
in 1 yr 9 mo
Patent 7842714 expires
Listed drug substance patent expiration.
Aug 15, 2029
in 3 yr 2 mo

Active ingredient

KETOROLAC TROMETHAMINE

Strength

0.45%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 022427

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8512717	Mar 07, 2028	in 1 yr 9 mo	Product
9192571	Mar 07, 2028	in 1 yr 9 mo	Product
7842714	Aug 15, 2029	in 3 yr 2 mo	SubstanceProduct